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Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification

Primary Purpose

Ossification, Heterotopic

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Celecoxib

About this trial

This is an interventional prevention trial for Ossification, Heterotopic focused on measuring Ossification, Heterotopic Ossification

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ISS ≥9 (a traumatic trans-tibial amputation is an ISS of 9)
Extremity Wound ≥75cm2 requiring operative intervention
Minimal age of 18 years

Exclusion Criteria:

The following co-morbidities will result in exclusion from study:

Coronary Artery Disease,
Diabetes Mellitus (IDDM or T2DM),
Peripheral Vascular Disease,
Age >65,
Connective tissue disorders,
Immunosuppression,
Clinically-evident peptic ulcer disease,
Substantial renal dysfunction (as assessed by a serum creatinine >1.5 or calculated creatinine clearance of <50),
Spine-injured patients who have recently received or are going to receive spinal fusion as determined by the evaluating neurosurgeon or orthopaedic spine surgeon at LRMC,
Severe penetrating or hemorrhagic traumatic brain injury,
Endoscopic gastrointestinal interventions,
Pregnancy or women of childbearing who does not take a pregnancy test and effective method of birth control.
Known hypersensitivity to Celebrex, Aspirin, other NSAIDs, or Sulfonamides.
History od Asthma, Urticaria, or allergic-type reactions after taking Aspirin or other NSAIDs.
Hepatic Impairment
Warfarin
Lithium
Drugs known to inhibit CYP2C9 Liver Enzymes
Subjects known or suspected to be poor CYP2C9 metabolizers
Concomitant use with ACE Inhibitors and Angiotension II Antagonists

Sites / Locations

Walter Reen National Military Medical Center BethesdaRecruiting
Landstuhl Military Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Celebrex

Control

Arm Description

Receive Celebrex

no placebo administered

Outcomes

Primary Outcome Measures

Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial

Incidence and severity of HO

Secondary Outcome Measures

Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial

Overall rate of impaired wound healing. Overall time to fracture union (if applicable) Overall rate of nonunions (if applicable) Overall rate of drug-related complications

Full Information

NCT ID

NCT01631669

First Posted

June 27, 2012

Last Updated

June 29, 2012

Sponsor

Walter Reed National Military Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01631669

Brief Title

Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification

Official Title

Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Unknown status

Study Start Date

May 2012 (undefined)

Primary Completion Date

June 2015 (Anticipated)

Study Completion Date

June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Walter Reed National Military Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Hypotheses: H1: Celecoxib, when given less than five days after injury will result in a statistical decrease in the incidence and/or severity of radiographically apparent Heterotopic Ossification when compared to controls. H2a: A biomarker profile will accurately predict which patients in the treatment group will respond to Celecoxib prophylaxis for Heterotopic Ossification. H2b: A biomarker profile will accurately predict which patients in the control group are at highest risk of developing Heterotopic Ossification

Detailed Description

This study is a prospective, randomized, controlled clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ossification, Heterotopic

Keywords

Ossification, Heterotopic Ossification

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Celebrex

Arm Type

Experimental

Arm Description

Receive Celebrex

Arm Title

Control

Arm Type

No Intervention

Arm Description

no placebo administered

Intervention Type

Drug

Intervention Name(s)

Celecoxib

Other Intervention Name(s)

Celebrex

Intervention Description

200 mg Q 12 hours orally

Primary Outcome Measure Information:

Title

Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial

Description

Incidence and severity of HO

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial

Description

Overall rate of impaired wound healing. Overall time to fracture union (if applicable) Overall rate of nonunions (if applicable) Overall rate of drug-related complications

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ISS ≥9 (a traumatic trans-tibial amputation is an ISS of 9) Extremity Wound ≥75cm2 requiring operative intervention Minimal age of 18 years Exclusion Criteria: The following co-morbidities will result in exclusion from study: Coronary Artery Disease, Diabetes Mellitus (IDDM or T2DM), Peripheral Vascular Disease, Age >65, Connective tissue disorders, Immunosuppression, Clinically-evident peptic ulcer disease, Substantial renal dysfunction (as assessed by a serum creatinine >1.5 or calculated creatinine clearance of <50), Spine-injured patients who have recently received or are going to receive spinal fusion as determined by the evaluating neurosurgeon or orthopaedic spine surgeon at LRMC, Severe penetrating or hemorrhagic traumatic brain injury, Endoscopic gastrointestinal interventions, Pregnancy or women of childbearing who does not take a pregnancy test and effective method of birth control. Known hypersensitivity to Celebrex, Aspirin, other NSAIDs, or Sulfonamides. History od Asthma, Urticaria, or allergic-type reactions after taking Aspirin or other NSAIDs. Hepatic Impairment Warfarin Lithium Drugs known to inhibit CYP2C9 Liver Enzymes Subjects known or suspected to be poor CYP2C9 metabolizers Concomitant use with ACE Inhibitors and Angiotension II Antagonists

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jonathan A Forsberg, MD

Phone

301-319-3403

jonathan.forsberg@med.navy.mil

First Name & Middle Initial & Last Name or Official Title & Degree

Frederick A Gage

Phone

301-319-8592

frederick.gage@med.navy.mil

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan A Forsberg, MD

Organizational Affiliation

Walter Reed National Military Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Walter Reen National Military Medical Center Bethesda

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20889

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jonathan A Forsberg, MD

Phone

301-319-3403

jonathan.forsberg@med.navy.mil

First Name & Middle Initial & Last Name & Degree

Frederick A Gage

Phone

301-319-8592

frederick.gage@med.navy.mil

First Name & Middle Initial & Last Name & Degree

Jonathan A Forsberg, MD

First Name & Middle Initial & Last Name & Degree

Benjamin K Potter, MD

First Name & Middle Initial & Last Name & Degree

Eric A Elster, MD

First Name & Middle Initial & Last Name & Degree

Frederick A Gage

First Name & Middle Initial & Last Name & Degree

Felipe Lisboa, MD

First Name & Middle Initial & Last Name & Degree

Tala Ghadimi, BS

Facility Name

Landstuhl Military Medical Center

City

Landstuhl

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brett Freedman, MD

brett.freedman@amedd.army.mil

First Name & Middle Initial & Last Name & Degree

Brett Freedman, MD

First Name & Middle Initial & Last Name & Degree

Hunter Martin, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

19411456

Citation

Forsberg JA, Pepek JM, Wagner S, Wilson K, Flint J, Andersen RC, Tadaki D, Gage FA, Stojadinovic A, Elster EA. Heterotopic ossification in high-energy wartime extremity injuries: prevalence and risk factors. J Bone Joint Surg Am. 2009 May;91(5):1084-91. doi: 10.2106/JBJS.H.00792.

Results Reference

background

PubMed Identifier

17332095

Citation

Potter BK, Burns TC, Lacap AP, Granville RR, Gajewski DA. Heterotopic ossification following traumatic and combat-related amputations. Prevalence, risk factors, and preliminary results of excision. J Bone Joint Surg Am. 2007 Mar;89(3):476-86. doi: 10.2106/JBJS.F.00412.

Results Reference

background

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Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification

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